1. Appearance: Off-white to light beige lyophilized powder.
2. PH: 6.4-7.4
3. Purity: more than 99% as determined by SDS-PAGE and HPLC
4. Residual DNA content:less than 0.5ng/g
5. Host cell protein residues content: less than 0.5μg/g protein.
6. Sterility test: negative
7. The results of abnormal toxicity check should meet the standard.
Healthgen recombinant human serum albumin (rHSA) has excellent
batch consistency. Using self-pollination rice as the bioreactor to
express the rHSA, with the world's advanced facility and top
production proceeding to extract and purify the rHSA, Healthgen can
ensure the excellent consistency of rHSA from different batches.
rHSA, manufactured in a GMP compliance facility with rigorous
quality control procedures, performs superior batch-to-batch
consistency. The purity is more than 99% and endotoxin is less than
The stability study includes acceleration stability test and long
term stability test. The results indicated that OsrHSA has
equivalent stability with pHSA. The current data supports the
stability of OsrHSA could be more than 2 years at 2~8℃.
The Specification of OsrHSA
|Identification- western blotting||Positive|
|Host cell DNA||NMT 0.5 ng/g protein|
|Sodium||NMT 160 mmol/L|
|Host cell protein||NMT 5 μg/g protein|
|Octanoate||0.140~0.180 mmol/g protein|
|Aluminum||NMT 200 μg/L|
|Ammonium sulfate||NMT 0.5 g/L|
|Sterility||Conforms to standard|
|Pyrogen test||Conforms to standard|
|Abnormal toxicity test||Conforms to standard|
Healthgen referred to CP (2010) and other recombinant HSA
manufactories quality standard and worked out the most restrictive
standard of OsrHSA. Healthgen innovated and developed two unique
items, host cell protein and host cell DNA. The test methods also
were reviewed by National Institutes for Food and Drug Control.
Healthgen has a professional quality control department, in which
50% of them have master's degree or higher. There are 14 employees
in the quality department, 9 of them are in QA and 5 are in QA. All
of them have rich experience in analysis research or quality
inspection. Every year there are more than 50 training courses,
which cover GMP, SOP, specification, hygiene, QA, QC issues, etc.
We strictly control the quality of our products to ensure that all
products into the market will be in line with quality standards.
Analytic instruments in QC are listed as below
|Osmotic pressure detector||Tianjin SMC30C-1|
|Kjeldahl apparatus||Jinan K9840|
|Karl fischer moisture meter||Mettler Toledo|
|Atomic absorption instrument||PE|
Healthgen Biotech has strong technical force and advanced and
complete protein expression and purification technology development
and large-scale production facilities. Self-developed rice
endosperm cell expression platform (OryzHiExp), which is domestic
initiative and the international leader, has such advantages: high
expression level, safety, scale-up easily, simple production
process and environmental protection etc. After 10 years of
unremitting efforts, Healthgen Biotech has established recombinant
protein expression and purification technology platform to
customize recombinant protein or peptide expression and
purification process service for pharmaceuticals, health products,
scientific research and industrial reagents. Using the OryzHiExp
platform, Healthgen Biotech has achievements in developing and
commercializing a series of medium ingredients, including
recombinant human serum albumin (OsrHSA), recombinant alphar-1
antitrypsin (OsrAAT), recombinant human lactoferrin (OsrLF),
recombinant human basic fibroblast growth factor (OsrbFGF),
recombinant human insulin-like growth factor-1 (OsrIGF-1) and
recombinant human transferring(OsrTF), which can provide a full set
of solutions for animal component free cell culture medium.